Senior Clinical Risk Evaluation Lead

Thornton Tomasetti; Plano (TX); Híbrido; USD 78.000 - 156.000; Jornada completa

Descripción de la vacante

Abbott in Plano, TX seeks a Senior Scientist/Program Manager for Clinical Risk Evaluation. You will develop and manage Risk Evaluation Files (REFs), perform risk analyses, and coordinate CER/SSCP activities across regulatory, clinical, and post-market teams.

The role requires strong project management, MDR/MEDDEV knowledge, and collaboration with CROs and internal stakeholders to ensure timely, compliant deliverables.

Formación

• Bachelor’s Degree in related field or equivalent experience.
• Minimum 6 years related work experience with strong domain understanding.
• Experience with MEDDEV 2.7/1 Rev. 4 and MDR Article 61.
• Quality system environment experience; ability to manage multiple projects.

Responsabilidades

• Create and maintain Risk Evaluation Files (REF) for Abbott products.
• Manage risk analyses and CER/SSCP development timelines.
• Oversee CROs and ensure on-time deliverables.
• Lead risk alignment committee meetings and cross-functional communication.
• Support regulatory responses and audits.

Conocimientos

Project management

Risk evaluation

Clinical data

Regulatory affairs

Cross-functional collaboration

Educación

Bachelor’s degree in related field

Master’s degree (preferred)

Descripción del empleo

Abbott in Plano, TX seeks a Senior Scientist/Program Manager for Clinical Risk Evaluation. You will develop and manage Risk Evaluation Files (REFs), perform risk analyses, and coordinate CER/SSCP activities across regulatory, clinical, and post-market teams.

The role requires strong project management, MDR/MEDDEV knowledge, and collaboration with CROs and internal stakeholders to ensure timely, compliant deliverables.